Institutional Review Board
Considerations for Human Subjects Research
The IRB will operate per normal schedule, holding committee meetings virtually. Remember, any modifications you make to your protocols as a result of the measures taken in response to the coronavirus outbreak need to be submitted to the IRB and approved before implementation.
For PIs conducting human subjects research, please remember that, as always, it is your responsibility to minimize risk to study participants. The IRB recommends that you review your current research protocols and consider modifying them to increase social distancing. For example, interviews and focus groups can be conducted remotely in most cases. You should immediately suspend all studies that require travel by subjects or in-person contact, unless there is a compelling benefit to the participant. In all situations, the IRB expects researchers to make participant safety a top priority. Requests to modify IRB protocols can be submitted via InfoEd, using the Study Modification Form. Please contact the IRB if you need further guidance. email@example.com
The Institutional Review Board (IRB) at WPI promotes and supports efforts to conduct innovative research at WPI while also helping researchers understand and comply with the ethical guidelines and regulatory requirements for research involving human subjects.
Federal mandate (The Common Rule, 45 CFR 46) and WPI policy require that the IRB review and approve all applicable research involving human subjects that is performed under the auspices of WPI, including engineering, physiological, behavioral, sociological, and nutritional studies, including projects involving human tissues, blood or images, questionnaires, and interviews.
IRB approval must be obtained before any human studies begin. For research involving minimal risk, approval is granted for one year and must be renewed annually. For research involving more than minimal risk, renewal frequency will be determined by the IRB upon approval.
Email the IRB with any questions or concerns.
Current IRB board members
- Kent Rissmiller, Interdisciplinary & Global Studies Division (Chair)
- Gabriel Johnson, Office of Sponsored Programs (Administrator)
- Ruth McKeogh, Interdisciplinary & Global Studies Division (IRB Manager)
- Antje Harnisch, Assistant Vice Provost of Research
- Sarah Strauss, Interdisciplinary & Global Studies Division
- Casey Burns, Director, Coalition for a Healthy Greater Worcester (Community Member)
- Daniel Dougherty, Computer Science
- Edward (Ted) Clancy, Electrical & Computer Engineering
- Chelsea Holland, Office of Sponsored Programs
Guidelines for Internet Surveys
To aid researchers, the WPI IRB has prepared a set of guidelines, including an example of an email request to participate, for implementing Internet or Web surveys. The guidelines do not cover issues of sampling or survey design, but rather methodological and ethical issues that arise in contacting respondents and soliciting their cooperation.
The IRB believes that researchers have an ethical obligation to follow best practices to assure valid results. Otherwise, it would be “unethical to burden respondents with a request for participating” (Groves et al., 2009:372). This means that before researchers begin a survey, they should consult appropriate references on how best to conduct surveys. A good reference for Internet surveys is Dillman, Smyth, and Christian’s Internet, Mail, and Mixed-Mode Surveys: The Tailored Design Method (2009). Another valuable resource is the set of “Best Practices” found on the American Association for Public Opinion Research, an organization dedicated to establishing professional standards for survey records.
The first step in implementing a survey is to contact respondents and ask them to participate. The sample letter (PDF), modeled after Figure 7.12 in Dillman, Smyth, and Christian (2009), contains the essential elements of an email request for an Internet survey. Notice that the request describes the topic of the survey, how or why the respondent was selected to participate, and how to access the survey; assures that participation is voluntary and all responses are confidential; and provides contact information for those who have questions or comments.
The sample email request describes an Internet survey in which researchers can identify who completes the survey. For surveys in which an individualized ID is not provided, where respondents simply click on the link to gain access to the survey, responses can be anonymous. In the latter case, the request should state that participation is voluntary and anonymous.
Although email contacts may seem relatively informal, it is still important to maintain the professionalism of the contacts. Therefore, you should not follow such common email practices as avoiding punctuation, using all capital letters, and using acronyms (e.g., BTW = “by the way” or FYI = “for your information”).
One common indicator of survey quality is the response rate—the number of people who complete the survey divided by the number who are contacted. Obtaining an adequate response rate in Internet surveys is especially difficult; however, there are several ways to increase the likelihood that a contact will respond. First, personalize the request as much as possible. Research has shown that students are more likely to respond to a salutation that is personalized (Dear [First Name]) than one that is not (Dear student). They are also more likely to respond to individual messages than to bulk email in which the message is sent to multiple recipients at once; bulk messages may also be flagged as spam. Additionally, as Dillman, Smyth, and Christian (2009:273) point out, the appearance of multiple email addresses “in the ‘To’ field raises serious ethical considerations, as confidentiality can no longer be ensured.”
Another means of increasing response rates is to use carefully spaced reminders or follow-up requests, which are a common practice in surveys. They are most effective when the content of the message is not repeated over and over but varies somewhat with each request. Usually, two or three follow-ups are used, as additional requests may irritate contacts and are not likely to yield significant gains.
Dillman, Don A., Jolene D. Smyth, and Leah Melani Christian, Internet, Mail, and Mixed-Mode Surveys: The Tailored Design Method, Hoboken, NJ: Wiley, 2009.
Groves, Robert M., Floyd J. Fowler, Jr., Mick P. Couper, James M. Lepkowski, Eleanor Singer, and Roger Tourangeau, Survey Methodology, 2nd Edition, Hoboken, NJ: Wiley, 2009.
Guidelines for Conflict of Interest
The integrity of research and the public’s faith in the research enterprise depends on the disclosure and management of conflicts of interest when present. It is important to note that our concern goes beyond genuine conflicts of interest and includes the potential for that appearance of such a conflict.
When research involves human subjects, it is possible that some subjects would decline to participate in research if they believe that the investigators may personally benefit from the research and may, therefore, have some incentive to manipulate the results of the research. For example, this may happen when an investigator (or a close family member of an investigator) has an ownership interest in, or a consulting relationship with, a company that expects to market a product pending the results of the research. Other examples of potential conflicts include:
- When investigators conduct applied or clinical research on a technology developed by the investigator or a member of his/her immediate family
- When investigators (or immediate family members) have a financial relationship with the sponsor of the research
- When investigators (or immediate family members) own shares of stock, stock options, or other interests in a business that will benefit from the success of the research
- When investigators (or immediate family members) receive royalties from the marketing of a drug, device, or technology that is the subject of the research
- When investigators receive payments from a sponsor for recruiting research subjects
Conflicts do not arise simply because the successful completion of the research may result in a conference presentation or publication for the investigators. This is true even if the investigators receive royalties from the publication of the research or receive honoraria or travel assistance associated with invited lectures based on the research.
COI Consent Language
Examples of content language to describe a conflict of interest include:
- A researcher(s) (family member, etc.) involved in the conduct of this study has (have) a financial interest in the success of the research. This research has the potential to demonstrate the effectiveness of [a medical device, etc.]. If the researcher(s) is (are) able to demonstrate the value of [the device], he/she/they could benefit from the marketing and sale of [the device]. You may see potential for financial gain as a reason to decline to participate in this study.
- An [external sponsor, corporation name] is paying the researchers to conduct this study. Thus, the [external sponsor] has a financial stake and the researchers have a financial interest in the success of this study. You may see this as a reason to decline to participate in this study.
Regulations & Ethical Guidelines
Government Agencies & Regulations
- Food & Drug Administration (FDA)
- National Institutes of Health (NIH)
- Office for Human Research Protections (OHRP, formerly OPRR)